NCT00043303

Brief Summary

The purpose of this research study is to test the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced liver fibrosis and cirrhosis in patients with chronic hepatitis C infections. IFN-g 1b is not currently approved for the treatment of liver fibrosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

August 7, 2002

Last Update Submit

October 29, 2007

Conditions

Liver FibrosisCirrhosis

Keywords

hepatitis Cliver fibrosisliver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Ishak fibrosis score

    52 weeks

Interventions

interferon gamma-1bDRUG

100 or 200 mcg, SQ, 3x per week

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Men or women 18 to 75 years * Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA * History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated * Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system. * Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted) * Must meet minimum blood chemistry requirements * Cannot have unstable or uncontrolled thyroid disease * Cannot have a variety of other diseases (listed in protocol * Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisFibrosisHepatitis C

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis

Study Officials

  • Steven Porter, MD

    InterMune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2002

First Posted

August 9, 2002

Study Start

September 1, 2001

Study Completion

November 1, 2003

Last Updated

November 1, 2007

Record last verified: 2007-10